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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Kinked (1339); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: 8781, serial (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturer representative on 2018-feb-20 regarding a patient receiving fentanyl (1291 mcg/ml at 199 mcg/day), bupivacaine (20 mg/ml at 3 mg/day), and dilaudid (0. 9 mg/ml at 0. 139 mg/day) via an implanted infusion pump. The indication for use was non-malignant pain. Other medications the patient was taking at the time of the event included amoxicillin, baclofen, cymbalta, pepcid, neurontin, synthroid, ativan, magog, imodium, prevalite, mycostatin, oxycodone, desyrel, bactrim, and claritin. The patient's medical history included paraplegic status, diabetes mellitus (dm), osteoporosis, decubitus ulcer, colostomy, "hz dvts," pyelonephritis, septic shock, urinary tract infections (utis) with sepsis, hypothyroidism, urostomy, metabolic encephalopathy, and acute renal failure. It was reported that the patient was having increased pain on an unknown date. A catheter dye study was done on (b)(6) 2018, but failed as the hcp was unable to aspirate the catheter. Surgery occurred on (b)(6) 2018 and the catheter was found to be kinked near the anchor. The catheter was cut above the kink and the hcp was able to aspirate cerebrospinal fluid (csf). The flow was sluggish, so the spinal segment was replaced. The issue was considered resolved and the patient's status at the time of report was alive - no injury. No further complications were reported or anticipated.
 
Manufacturer Narrative
Refers to the main device, the other relevant component includes: product id 8781 (b)(4) implanted: (b)(6)2015 explanted: (b)(6)2018; product type catheter; ubd: (b)(4)2017; (b)(6). Of note, only the catheter was returned for analysis. Evaluation of implantable catheter (b)(4) revealed no significant anomalies. However, only a small segment of the catheter was returned for analysis. Analysis identified melting damage on the catheter consistent with explant damage. Device code (b)(4) has been added. The evaluation codes have also been updated. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7287003
MDR Text Key100611080
Report Number3004209178-2018-03726
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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